New Non-Prescription drug guidelines

The Australian Guidelines for the Registration of Drugs (AGRD): Volume 2, Non-Prescription Drugs is currently being discussed with industry bodies and is expected to be available from early July. The Guidelines have been revised, expanded and clarified and will follow the same user-friendly format as the Changes to Drug Products document, introduced in July 1994. Copies will be available for purchase from the TGA Information Office.

Multi-dose vials: cross contamination

The 175th meeting (1994/6) of the Australian Drug Evaluation Committee (ADEC) has considered the implications of the recent Australian National Council on AIDS (ANCA) report on infection control, as it related to multi-dose containers. The ANCA report highlighted the need to reduce the risk of blood borne diseases.

This concern is consistent with that of the ADEC, which has recommended rejection of a number of applications for multi-dose vials in recent years, in accordance with the recommendations of the Pharmaceutical Subcommittee. However, the ADEC has accepted that there may be special needs for multi-dose vials, eg. drugs such as insulin, or preparation by hospital pharmacists of multi-dose infusions, under sterile conditions.

The ADEC has recommended that where possible, multi-dose containers should be phased out. No new applications for multi-dose vials should be accepted, unless the sponsors of these products are able to provide cogent arguments in support of the appropriateness of this presentation (Res. No. 5578).

TGAL workshop: high performance liquid chromatography method validation

The TGAL will be conducting high performance liquid chromatography (HPLC) method validation workshops in Canberra in July and August. The workshops are designed for laboratory workers involved in developing and validating analytical methods.

The workshops will cover the theoretical background to method validation in relation to pharmaceuticals and will use practical examples to look at the elements of HPLC method validation and some of the pitfalls that can occur. Comparisons will be made with other techniques used in pharmaceutical analysis.

The cost for the three-day workshop is $1,100 which includes lunch and a workshop dinner. Enrolment in any workshop will be limited to 12 persons to ensure that participants gain "hands-on" experience.

• Workshop 1 - 24, 25, 26 July
• Workshop 2 - 2, 3, 4 August
• Workshop 3 - 14, 15, 16 August

Additional workshops will be scheduled according to demand.

Litigation relating to decisions under the Therapeutic Goods Act - an update

The Therapeutic Goods Act 1989 provides for appeals to be made against most decisions of the Secretary of the Department of Health and Family Services. An application for review of the Secretary's decision may be made to the Minister and, if this is unsuccessful, application may be made to the Administrative Appeals Tribunal (AAT). A further appeal may be made to the Federal Court. The number of initial decisions in respect of which appeals were received by the Minister between 1.7.93 and 31.12.94 was as follows:

Half year ending	Number
31.12.93	20
30.06.94	8
31.12.94	8

All these appeals were handled by delegates of the Minister. Twenty-nine related to registrable drugs, two to listable drugs and five to listable devices. In eight cases the appeal was successful or partially successful, and in 23 the initial decision was confirmed. Five appeals were ruled invalid. In four of these 36 cases, the appellant appealed further, to the Administrative Appeals Tribunal (AAT). In one of these appeals to the AAT the applicant was successful, one matter was settled by agreement between the parties, in one the Minister's decision was confirmed, and one was withdrawn.

1996 ADEC dates

Meeting No	Agenda cut-off	Meeting date
1996/1 (181)	16 January	8-9 February
1996/2 (182)	12 March	11-12 April
1996/3 (183)	14 May	6-7 June
1996/4 (184)	9 July	1-2 August
1996/5 (185)	10 September	3-4 October
1996/6 (186)	12 November	5-6 December

Prescription Medicines Advisory Board disbanded

The Prescription Medicines Advisory Board has been disbanded by the Minister. The Board was established in 1992 following a recommendation in the Baume Report that there be an advisory board to assist the TGA National Manager.

The Board had completed its task, and fulfilled the need for its establishment. It was a useful mechanism for the National Manager to receive feedback on the progress and success of the various changes implemented over the last three years. Drug evaluation procedures are now streamlined and there is much improved interaction and consultation with industry, professional groups and consumers.

Continuing contact will be maintained with industry through the TGA Industry-Government Consultative Committee, and with professional practice through the Australian Drug Evaluation Committee (ADEC). Contact will be maintained with consumers through new consultative mechanisms which will be established through further discussion between the National Manager and the Consumers' Health Forum of Australia.